FDA UDI
In Commercial Distribution
🇺🇸 United States
FlexStep
DI: 05714420041295
·
Model: FlexStep V2
·
Liftup A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FlexStep
- Primary DI
- 05714420041295
- Version / Model
- FlexStep V2
- Catalog Number
- 104129
- Company Name
- Liftup A/S
- Labeler DUNS
- 308619001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-03
- Public Version
- 1
- Public Version Date
- 2021-06-11
- Public Version Status
- New
- Public Device Record Key
- 4b3ba6ce-164d-4946-8b0b-b381c0aa6531
Device Description
FlexStep V2, 1000, 5 step, outdoor
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PCE | Permanently Mounted Wheelchair Platform Lift | Physical Medicine | 890.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30036 | Assistive passenger lift | An elevator designed to be used and operated by a person with a disability and to accommodate their assistive devices (e.g., a wheelchair) which move in a vertically shaft (up and down) to provide a method of transport between two or more vertical levels (e.g., floors in a building and ship decks). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05714420041295 | GS1 |
Customer Contacts
- Phone
- +1 844 543 8878
- [email protected]